Over-the-counter ranitidine is used to treat and prevent heartburn caused by acid indigestion. It works by decreasing the amount of acid made in your stomach.
FDA Update - April 2020
Prescription strength ranitidine is used to treat ulcers caused by gastroesophageal reflux disease (GERD), which is a condition where the stomach makes too much acid. The U.S. Food and Drug Administration (FDA) has requested all manufacturers to remove all ranitidine prescription and over-the-counter drug products from the market immediately.
The FDA has learned that that some ranitidine medicines, such as the brand-name drug Zantac, contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA). According to the FDA, NDMA is known as a substance which could cause cancer in humans. NDMA is a known environmental contaminant in the U.S. and found in water, vegetables, dairy products, and meats.
As part of their ongoing investigation, the FDA has now determined the impurity in some ranitidine products increases as time goes on when stored over room temperatures. For this reason, ranitidine drug products will not be available for use in U.S. at this time.
The Italian Drug Agency stated they are recalling all versions of ranitidine containing an active ingredient made by Saraca Laboratories, a manufacturer based in India. They are still testing for impurities with other manufacturers. Health Canada has requested that companies stop distributing ranitidine drugs in Canada while they assess the NDMA impurities.
The European Medicines Agency is currently evaluating data to assess if patients using ranitidine are at a risk due to NDMA impurities and will provide information as it comes in. They are working on guidance for avoiding nitrosamines. Check here for updates.
The Drugs Standard Control Organization (CDSCO) of India is currently investigating a probable presence of NDMA in ranitidine and has advised state regulators to verify products and take appropriate measures to ensure patient safety.
We advise patients to check with their providers and/or pharmacists for any updates on possible recalls of ranitidine and to discuss other treatment options if necessary.
FDA Update - September 2019
Over-the-counter ranitidine is used to treat and prevent heartburn caused by acid indigestion. It works by decreasing the amount of acid made in the stomach. Prescription strength ranitidine is used to treat ulcers caused by gastroesophageal reflux disease (GERD), which is a condition where the stomach makes too much acid.
The U.S. Food and Drug Administration (FDA) has discovered that some ranitidine medicines, such as the brand-name drug Zantac, contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA). According to the FDA, NDMA is known as a substance which could cause cancer in humans. NDMA is a known environmental contaminant in the US and found in water, vegetables, dairy products, and meats. The FDA is working with regulators around the world to determine the direct source of the ranitidine impurity.
The FDA is not asking for patients to stop taking ranitidine at this time. Patients taking OTC ranitidine do have the option of switching to another OTC medication. For patients taking prescription ranitidine please consult your healthcare provider before discontinuing.
The Italian Drug Agency stated they are recalling all versions of ranitidine containing an active ingredient made by Saraca Laboratories, a manufacturer based in India. They are still testing for impurities with other manufacturers.
Health Canada has requested that companies stop distributing ranitidine drugs in Canada while they assess the NDMA impurities. The page to this notice seems down but you can check back at a later time here.
The European Medicines Agency is currently evaluating data to assess if patients using ranitidine are at a risk from NDMA impurities and will provide information about this as soon. They are working on guidance for avoiding nitrosamines. Check here for updates.
The Drugs Standard Control Organization (CDSCO) of India is currently investigating a probable presence of NDMA in ranitidine and has advised state regulators to verify products and take appropriate measures to ensure patient safety. We advise patients to check with their providers and/or pharmacists for any updates on possible recalls of ranitidine, and to discuss other treatment options, if necessary.
Over-the-counter ranitidine is used to treat and prevent heartburn caused by acid indigestion.
It works by decreasing the amount of acid made in your stomach.
FDA Update - April 2020
Prescription strength ranitidine is used to treat ulcers caused by gastroesophageal reflux disease (GERD), which is a condition where the stomach makes too much acid. The U.S. Food and Drug Administration (FDA) has requested all manufacturers to remove all ranitidine prescription and over-the-counter drug products from the market immediately.
The FDA has learned that that some ranitidine medicines, such as the brand-name drug Zantac, contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA). According to the FDA, NDMA is known as a substance which could cause cancer in humans. NDMA is a known environmental contaminant in the U.S. and found in water, vegetables, dairy products, and meats.
As part of their ongoing investigation, the FDA has now determined the impurity in some ranitidine products increases as time goes on when stored over room temperatures. For this reason, ranitidine drug products will not be available for use in U.S. at this time.
The Italian Drug Agency stated they are recalling all versions of ranitidine containing an active ingredient made by Saraca Laboratories, a manufacturer based in India. They are still testing for impurities with other manufacturers. Health Canada has requested that companies stop distributing ranitidine drugs in Canada while they assess the NDMA impurities.
The European Medicines Agency is currently evaluating data to assess if patients using ranitidine are at a risk due to NDMA impurities and will provide information as it comes in. They are working on guidance for avoiding nitrosamines. Check here for updates.
The Drugs Standard Control Organization (CDSCO) of India is currently investigating a probable presence of NDMA in ranitidine and has advised state regulators to verify products and take appropriate measures to ensure patient safety.
We advise patients to check with their providers and/or pharmacists for any updates on possible recalls of ranitidine and to discuss other treatment options if necessary.
FDA Update - September 2019
Over-the-counter ranitidine is used to treat and prevent heartburn caused by acid indigestion. It works by decreasing the amount of acid made in the stomach. Prescription strength ranitidine is used to treat ulcers caused by gastroesophageal reflux disease (GERD), which is a condition where the stomach makes too much acid.
The U.S. Food and Drug Administration (FDA) has discovered that some ranitidine medicines, such as the brand-name drug Zantac, contain low levels of a nitrosamine impurity called N-nitrosodimethylamine (NDMA). According to the FDA, NDMA is known as a substance which could cause cancer in humans. NDMA is a known environmental contaminant in the US and found in water, vegetables, dairy products, and meats. The FDA is working with regulators around the world to determine the direct source of the ranitidine impurity.
The FDA is not asking for patients to stop taking ranitidine at this time. Patients taking OTC ranitidine do have the option of switching to another OTC medication. For patients taking prescription ranitidine please consult your healthcare provider before discontinuing.
The Italian Drug Agency stated they are recalling all versions of ranitidine containing an active ingredient made by Saraca Laboratories, a manufacturer based in India. They are still testing for impurities with other manufacturers.
Health Canada has requested that companies stop distributing ranitidine drugs in Canada while they assess the NDMA impurities. The page to this notice seems down but you can check back at a later time here.
The European Medicines Agency is currently evaluating data to assess if patients using ranitidine are at a risk from NDMA impurities and will provide information about this as soon. They are working on guidance for avoiding nitrosamines. Check here for updates.
The Drugs Standard Control Organization (CDSCO) of India is currently investigating a probable presence of NDMA in ranitidine and has advised state regulators to verify products and take appropriate measures to ensure patient safety. We advise patients to check with their providers and/or pharmacists for any updates on possible recalls of ranitidine, and to discuss other treatment options, if necessary.
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The Tier 1 icon means that an online pharmacy accredited by PharmacyChecker only fills prescription orders through their own pharmacy or dispensing pharmacy partners in Australia, Canada, Israel, New Zealand, United Kingdom, or the U.S. Such countries are known to have equally advanced pharmaceutical and pharmacy regulatory systems. Please note that all PharmacyChecker-accredited online pharmacies (tier 1 and non-tier 1) meet the same high standards as identified in the PharmacyChecker Verification Program.
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icon means that this online pharmacy accredited by PharmacyChecker fills prescription orders through either their own pharmacy or dispensing pharmacy partners located in Australia, India, Mauritius, New Zealand, Turkey, the UK, or Canada. Please note that all PharmacyChecker-accredited online pharmacies (tier 1 and non-tier 1) meet the same high standards as identified in the PharmacyChecker Verification Program.
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| ID | PCCARD | BIN | 610312 |
| GRP | NXAACC | PCN | 01 |
